Anivac VHD Suspension for injection for rabbits

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Rabbit haemorrhagic disease, strain RHDV PHB 98

Disponible des:

Pharmagal Bio s.r.o

Codi ATC:

QI08AA01

Designació comuna internacional (DCI):

Rabbit haemorrhagic disease, strain RHDV PHB 98

Dosis:

minimum 1 PD90

formulario farmacéutico:

Suspension for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Rabbits

Área terapéutica:

rabbit haemorrhagic disease virus

indicaciones terapéuticas:

Immunological - Inactivated Vaccine

Estat d'Autorització:

Authorised

Data d'autorització:

2008-11-10

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Anivac VHD Suspension for injection for rabbits
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of vaccine (0.5 ml) contains:
_Active substances:_
Inactivated Rabbit Haemorrhagic Disease Virus strain RHDV PHB98
…… min. 1 PD
90
*
_Adjuvant:_
Aluminium hydroxide gel
.................................................................................
1.3 mg
_Excipients:_
Formaldehyde
………………………………………………………………
0.55 mg
Thiomersal
………………………………………………………………
0.05 mg
For a full list of excipients, see section 6.1.
* Protective dose for minimum 90 % of vaccinated animals
3 PHARMACEUTICAL FORM
Suspension for injection.
Suspension of red-brown colour with easily shakeable sediment of
inactivated RHDV adsorbed on aluminium
hydroxide gel that forms 40-60 % of the vaccine if left undisturbed.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Rabbit.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of rabbits to prevent mortality caused by RHD
virus
Onset of immunity: 7 days
Duration of immunity: 1 year based on field data without controlled
challenge
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
No information is available on the use of the vaccine in seropositive
animals including those with maternally derived
antibodies; therefore in situations where high antibody levels are
expected the vaccination protocol should be planned
accordingly.
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